The U.S. Food and Drug Administration (FDA) posted a Consumer Update today, warning consumers not to rely upon any over-the-counter hand sanitizers or similar over-the-counter products making claims that they kill bacteria such as MRSA, E. coli, Salmonella, or H1N1 flu or prevent infections caused by these serious bacteria. These claims are false and illegal, warns the FDA.

At the same time, the FDA issued Warning Letters today to four companies that make or distribute products making such claims, directing them to cease the cited legal violations within 15 days or face seizure of their products or other legal action.

“FDA has not approved any products claiming to prevent infection from MRSA, E. coli, Salmonella, or H1N1 flu, which a consumer can just walk into a store and buy” says Deborah Autor, the compliance director at FDA’s Center for Drug Evaluation and Research. “These products give consumers a false sense of protection.”

Warning to Consumers

The FDA alerted consumers that some hand sanitizers and antiseptic products are being falsely labeled with claims that they can prevent MRSA infections or other serious infections.

“Don’t believe them. These statements are unproven,” wrote the FDA.

MRSA (methicillin-resistant Staphylococcus aureus) is a bacterium that can cause severe and life-threatening infections which do not respond to standard treatment with the antibiotic methicillin, according to the FDA.

“Staphylococcus aureus itself is a very aggressive organism,” says Edward Cox, M.D., M.P.H., director of FDA’s Office of Antimicrobial Products. “It’s often associated with patients in hospitals who have weakened immune systems, but the bacterium can also cause significant skin infections and abscesses in a normal, healthy person. And it can get into the bloodstream and, less frequently, may involve the heart valve, which is very difficult to treat.”

MRSA, the antibiotic-resistant strain of Staphyolococcus aureus, is even more difficult to treat. “With MRSA, a number of the antibiotic drugs we typically used often don’t work, so we lose treatment options we used to rely upon,” says Cox.

“Consumers are being misled if they think these products you can buy in a drug store or from other places will protect them from a potentially deadly infection,” says Deborah Autor, compliance director at FDA’s Center for Drug Evaluation and Research.

In its Consumer Update posted today, the FDA warns consumers to beware of unproven product claims, whether the product is sold in a retail store or over the Internet.

Examples of unproven product claims cited by the FDA, and which it found on product labels, include:

“kills over 99.9% of MRSA”

“helps prevent skin infections caused by MRSA and other germs”

“is effective against a broad spectrum of pathogens, including MRSA”

“prevents infection from the bacterium E. coli and the H1N1 flu virus” (found on a hand sanitizing lotion)

“Don’t buy over-the-counter hand sanitizers or other products that claim to prevent infection from MRSA, E. coli, Salmonella, flu, or other bacteria or viruses.

Ask your pharmacist or other health care professional for help in distinguishing between reliable and questionable information on product labels and company websites.

In general, wash hands often, especially before handling food, to help avoid getting sick. Wash hands with warm water and soap for 20 seconds. For children, this means the time it takes to sing the “Happy Birthday” song twice.

Advertise/ Sponsor this Site

This site is published by Care-Help LLC, a Florida limited liability company, which earns advertising revenues to support and maintain HelpingYouCare® for the benefit of family caregivers, seniors, and our communities and constituents. Read more about HelpingYouCare®...

Contribute

Your support is much appreciated and used to help maintain this site. Our mission is to serve family caregivers, seniors and our communities. Read more...»

Care-Help LLC, publisher of HelpingYouCare®, is a Florida limited liability company; not a 501(c)(3) charity. Therefore, contributions are not tax-deductible.

Contribute Content

Write and contribute articles, posts or other content for publication on this Site. Propose to write a column for the site. Or share with the HelpingYouCare® Community any useful information & resources you have found.

The Contents on this Site do not constitute medical, legal, financial or other professional advice, and may not be relied upon as such. The HelpingYouCare® website and its owner, Care-Help LLC, do not endorse or recommend and are not responsible for the information on other websites to which we may link, or for any content posted or linked on this site.

By accessing this website, you agree to the Legal Terms for this site.